MAUDE Adverse Event Report: OSCOR INC. MEDTRONIC REUSABLE EXTENSION CABLE; CABLE, ELECTRODE

Model Number	59312
Medical Device Problem Codes	Invalid Sensing (2293); High Sensing Threshold (2574); Low Sensing Threshold (2575)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is part of an internal retrospective review of complaints, conducted by oscor as a result of process improvements made to the complaint system to ensure proper medical device reporting is maintained.As part of the detailed review, this event has been determined to be reportable.This initial mdr is being submitted to meet our requirements of reporting.A follow-up will be submitted as soon as the investigation is complete.
Event or Problem Description
Over-sensing and over pacing.Temporary pace maker (tpm) lead was inserted in the patient and as soon as tpm lead was connected to the external pacing generator (epg) there was over-sensing initially, later it started under-sensing qrs and paced on t-wave, causing the patient to go into life threatening ventricular arrhythmia.The epg was replaced immediately after cardioversion.
Additional Manufacturer Narrative
Oscor received addition information from the customer that this event was inadvertently reported twice, which resulted in oscor sending this report number 1035166-2017-00027 as a duplicate.The initial and final original report was submitted to the fda by oscor against report number 1035166-2016-00014.Based upon this additional information, oscor recognizes report number 1035166-2016-00014 as the official report and considers report number 1035166-2017-00027 closed.

• Brand Name: MEDTRONIC REUSABLE EXTENSION CABLE
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• MDR Report Key: 6437536
• Report Number: 1035166-2017-00027
• Device Sequence Number: 10838512
• Product Code: IKD
• UDI-Device Identifier: 00885672101930
• UDI-Public: 00885672101930
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K070926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 59312
• Device Catalogue Number: 59312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2017
• Supplement Report FDA Received Date: 06/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention